Estudio en Dos Partes, Multicéntrico, Doble Ciego, Aleatorizado, Controlado con Placebo para Evaluar la Eficacia, Seguridad y Mantenimiento del Efecto de Seltorexant 20 mg como Terapia Complementaria a Antidepresivos en Pacientes Adultos y Adultos Mayores con Trastorno Depresivo Mayor con Síntomas de Insomnio

ReclutandoFase 3ClinicalTrials.gov

ID: NCT06559306Tipo: INTERVENTIONALInicio: 25 de jul de 2024Fin estimado: 30 de dic de 2026

Resumen

El propósito de este estudio es conocer qué tan bien funciona seltorexant, y también evaluar la seguridad y el efecto de mantenimiento de seltorexant en comparación con placebo como terapia complementaria a un antidepresivo para mejorar los síntomas depresivos en participantes con trastorno depresivo mayor con síntomas de insomnio (TDMSI) que han tenido una respuesta inadecuada al tratamiento antidepresivo actual con un inhibidor selectivo de la recaptación de serotonina (ISRS) o un inhibidor de la recaptación de serotonina y norepinefrina (IRSN).

Elegibilidad

Edad mínima: 18 YearsEdad máxima: 74 YearsSexo: ALL

Criterios de inclusión

Participants in part 1 and direct enrollers to part 2:
Meet DSM-5 MDD, without psychotic features based upon clinical assessment and confirmed by the structured clinical interview for DSM-5 Axis I disorders-clinical trials version (SCID-CT) diagnosed with first depressive episode prior to age 60
Have had an inadequate response to at least 1 but no more than 2 antidepressants, administered at an adequate dose and duration in the current episode of depression. An inadequate response is defined as less than (\<) 50% reduction but with some improvement (that is, improvement greater than \[\>\] 0%) in depressive symptom severity with residual symptoms other than insomnia present, and overall good tolerability, as assessed by the MGH-ATRQ, and this must include the participant's current antidepressant treatment
Is receiving and tolerating well any one of the following SSRI or SNRI for depressive symptoms at screening, in any formulation and available in the participating country: citalopram, duloxetine, escitalopram, fluvoxamine, fluoxetine, milnacipran, levomilnacipran, paroxetine, sertraline, venlafaxine, desvenlafaxine, vilazodone, or vortioxetine at a stable dose (at therapeutic dose level) for at least 6 weeks
Having a major depressive episode of at least moderate severity, as assessed with 17-item Hamilton Depression Rating Scale, implemented through the Structured Interview Guide (SIGH-D) in a blinded manner at screening and must not demonstrate a clinically significant improvement from the beginning to end of screening.
Participants entering after completing part 1:
Must have completed Part 1 DB treatment phase
Can consistently tolerate study drug (at the end of Part 1), and there is no additional safety risk for the participant if they proceed to Part 2
Was able to consistently follow the study procedures in Part 1 as judged by the investigator.
Must be medically stable based on clinical laboratory tests

Criterios de exclusión

Has a recent (last 3 months) history of, or current signs and symptoms of, severe renal insufficiency clinically significant or unstable cardiovascular, respiratory, gastrointestinal, neurologic, hematologic, rheumatologic, immunologic or endocrine disorders and uncontrolled Type 1 or Type 2 diabetes mellitus
Has a history of narcolepsy and seizures
Has current signs/symptoms of hypothyroidism or hyperthyroidism
Participants taking thyroid supplementation for antidepressant purposes
Has Cushing's disease, Addison's disease, primary amenorrhea, or other evidence of significant medical disorders of the HPA axis

Intervenciones

drug

Seltorexant

Seltorexant will be administered orally.

drug

Placebo

Matching Placebo tablets will be administered orally.

drug

Selective Serotonin Reuptake Inhibitor (SSRI)/Serotonin-Norepinephrine Reuptake Inhibitor (SNRI)

SSRI/SNRI will be administered orally.

Ubicaciones

Fundacion para el Estudio y Tratamiento de las Enfermedades Mentales

Buenos Aires, Argentina

RECRUITING

CEN Consultorios Especializados en Neurociencias

Córdoba, Argentina

RECRUITING

Instituto Medico DAMIC

Córdoba, Argentina

RECRUITING

Centro Medico Luquez

Córdoba, Argentina

RECRUITING

Sanatorio Prof Leon S Morra S A

Córdoba, Argentina

RECRUITING

INSA Instituto de Neurociencias San Agustín

La Plata, Argentina

RECRUITING

C I A P Centro de investigacion y Asistencia en Psiquiatria

Rosario, Argentina

RECRUITING

Clinica El Jardin

Santiago del Estero, Argentina

RECRUITING

Patrocinadores

PrincipalJanssen Research & Development, LLC

Contactos

Study Contact

CONTACT

Participate-In-This-Study1@its.jnj.com 844-434-4210

Aviso: La información de este ensayo proviene de fuentes públicas y tiene carácter exclusivamente informativo. No constituye asesoramiento médico, regulatorio ni de ningún otro tipo. Las traducciones son automatizadas y no poseen validez oficial. Consultá siempre con un profesional de la salud. Ver Términos de Uso.

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